Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema.

• The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours).

• For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily).

• The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III

• For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea.

• The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients.

• To our knowledge no study has explored these aspects before.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Collaborator: Fondazione Salvatore Maugeri
• Treatments: Bromides; Glycopyrrolate

Criteria

Inclusion Criteria:

• Signature of informed consent

• COPD patients with age raging from 50 to 85 years old

• Patients with at least a history of COPD of one year

• COPD patients clinically stable in the last three months

• COPD subjects with Forced Expiratory Volume at one second (FEV1)<50% of predicted value

• COPD subjects with Residual Volume (RV) >125% predicted value

• FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (LLN)

• COPD former or active smokers with at least a smoking history of 20 pack year

Exclusion Criteria:

• Acute Bronchial Exacerbation at recruitment

• Fertile women with age between 18 and 50 years old or with active period

• Pregnancy

• Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment.

• FEV1/FVC more than 70% of predicted value in basal conditions

• FEV1 more than 70% of predicted value in basal conditions

• Known deficit of alpha 1 antitrypsin

• Subjects that underwent a Lung Volume Reduction Surgery (LVRS)

• Subjects with known positivity to Human Immunodeficiency Virus (HIV)

• Misuse of alcool or drugs

• Lack of compliance in performing respiratory tests

• Subjects not capable to follow the study prescriptions because of psychic disorders or language problems.

• Long Term Oxygen Therapy with flows > 6 litres per minute (l/min) at rest